Coricidin Hbp Nighttime Multi-Symptom Cold

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates headache, sore throat, runny nose, minor aches and pains, cough due to minor throat and bronchial irritation, sneezing, and fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the prescribed dose is 30 mL, to be taken using the dosing cup provided, every 6 hours as needed for symptom relief. It is imperative that the total daily dosage does not exceed 120 mL, which corresponds to 4 doses within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under the age of 12, it is advised to consult a doctor before administration to determine the appropriate dosage.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other products containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease. This contraindication extends for 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI before using this product.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, which should not exceed 120 mL (4 doses) within a 24-hour period. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen, as well as in patients who consume three or more alcoholic drinks daily while using this product.

Acetaminophen may induce severe skin or allergic reactions. Symptoms indicative of such reactions include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. In the event of any skin or general allergic reaction, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly.

It is imperative to keep this product out of reach of children. In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) without delay, as quick medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: fever worsens or lasts more than three days; cough recurs or is accompanied by a rash or headache that persists; pain, cough, or nasal congestion worsens or lasts more than seven days; new symptoms develop; or if redness or swelling is observed.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 120 mL (4 doses) within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin or allergic reactions associated with acetaminophen. Symptoms of such reactions may include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases where a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should also stop use and consult a doctor if fever worsens or lasts more than three days, if a cough recurs or occurs with a rash or headache that persists, or if pain, cough, or nasal congestion worsens or lasts more than seven days. The emergence of new symptoms or the presence of redness or swelling should also prompt a consultation with a healthcare provider.

Before using this product, patients with liver disease, chronic cough (such as that associated with smoking, asthma, or emphysema), difficulty urinating due to an enlarged prostate gland, breathing problems (such as emphysema or chronic bronchitis), cough with excessive phlegm, glaucoma, or those on a sodium-restricted diet should seek medical advice.

Additionally, patients taking the blood-thinning medication warfarin or those using sedatives or tranquilizers should consult a doctor or pharmacist prior to use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Coricidin Hbp Nighttime Multi-Symptom Cold (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before using this product. For adolescents aged 12 years and older, the recommended dosage is 30 mL taken every 6 hours as needed, not to exceed 120 mL (4 doses) in a 24-hour period unless directed by a physician.

Caution is advised as excitability may occur, particularly in children. It is essential to keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of specific guidance may necessitate individualized assessment and monitoring based on clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily amount of 120 mL (4 doses) within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

It is also advised that patients with compromised liver function limit their alcohol intake to fewer than three alcoholic drinks per day while using this product. Monitoring of liver function is recommended for patients with existing liver conditions or those who consume alcohol regularly, to ensure safety and prevent potential hepatotoxicity.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, symptomatic treatment, and, if applicable, the use of specific antidotes. It is crucial to consult local poison control guidelines and the product's prescribing information for detailed management protocols.

In all instances of suspected overdose, healthcare professionals should ensure that appropriate measures are taken to safeguard the patient's health and well-being.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use due to potential teratogenic effects.

Excitability may occur, particularly in children, alongside marked drowsiness. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

No specific information is available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

Reports of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been received. Additionally, cases of acute liver failure have been reported in patients taking acetaminophen, particularly among those who exceeded the recommended dosage or used multiple products containing acetaminophen. Allergic reactions, including anaphylaxis, have also been documented in patients using this product.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be encouraged to consult a doctor before using this product if they have any of the following conditions: liver disease; a chronic cough, such as that associated with smoking, asthma, or emphysema; difficulty urinating due to an enlarged prostate gland; a breathing problem like emphysema or chronic bronchitis; a cough accompanied by excessive phlegm; glaucoma; or if they are on a sodium-restricted diet.

Additionally, patients should be advised to speak with a doctor or pharmacist prior to use if they are currently taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

While using this product, patients may experience excitability, particularly in children, and marked drowsiness. It is important to instruct patients to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery, since alcohol, sedatives, and tranquilizers can enhance drowsiness.

Patients should be instructed to discontinue use and consult a doctor if any of the following occur: fever worsens or persists for more than three days; a cough recurs or is accompanied by a rash or headache that lasts; pain, cough, or nasal congestion worsens or lasts more than seven days; new symptoms develop; or if there is any redness or swelling present.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20º-25ºC (68º-77ºF) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Coricidin Hbp Nighttime Multi-Symptom Cold, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)